(16 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.
Class 1 Latex Patient Examination Glove 80LYY, powdered with absorbable dusting powder, which meets all the requirements of ASTM Standard D3578-01a52 and FDA Water Leak Test.
The provided text describes the acceptance criteria and performance data for Powdered Latex Examination Gloves manufactured by SPI GLOVES SDN. BHD. This document is a 510(k) premarket notification for a medical device.
Please note that this document is for a physical product (gloves) and not an AI/ML powered device, so several of the requested categories (like MRMC study, effect size, human-in-the-loop, etc.) are not applicable and will be marked as "N/A".
1. A table of acceptance criteria and the reported device performance
| TEST | Acceptance Criteria (ASTM D3578-01aE2) | Reported Device Performance (Powdered Latex Exam Gloves) |
|---|---|---|
| 1. Watertight (1000 ml) | AQL=2.5% | Pass GI (AQL=2.5%) |
| 2. Length (mm) | Min 230 | 240 mm minimum for all sizes |
| 3. Palm width (mm) | ||
| Size XS | - | 110 mm |
| 4. Thickness (mm) (Single Layer) | ||
| Finger | Min 0.08 | 0.10 minimum |
| Palm | Min 0.08 | 0.10 minimum |
| 5. Physical Properties Before Aging | ||
| Tensile Strength (Mpa) | Min 14.0 | 28.0 |
| Ultimate Elongation (%) | Min 650 | 982 |
| 5. Physical Properties After Aging | ||
| Tensile Strength (Mpa) | Min 14.0 | 26.9 |
| Ultimate Elongation (%) | Min 500 | 970 |
| 6. Powder Content | - (FDA Requirement) | Below 10 mg / dm2 |
| 7. Protein Content | - (FDA Requirement) | Below 200 microgram / dm2 |
| 8. Biocompatibility Test | Pass | Pass (Primary Dermal Irritation Test, Guinea Pig Sensitization) |
2. Sample size used for the test set and the data provenance
The document does not explicitly state a specific sample size for the tests. The performance data is reported as meeting the standards, implying that adequate samples were tested for each criterion according to ASTM D3578-01aE2 and FDA requirements. The data provenance is from Malaysia (SPI GLOVES SDN. BHD. is located in Ipoh, Perak, Malaysia). The data appears to be prospective as it represents the performance testing conducted by the manufacturer for their product prior to submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
N/A. This is a physical product (gloves) undergoing standardized physical and chemical tests, not an AI/ML device requiring expert interpretation of medical images or data. The "ground truth" is defined by the objective measurement standards of ASTM D3578-01aE2 and FDA requirements.
4. Adjudication method for the test set
N/A. The testing involves objective measurements against established technical standards (ASTM D3578-01aE2) and FDA requirements. There is no human adjudication process described beyond the performance of the specified tests.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
N/A. This is not an AI/ML powered device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
N/A. This is not an AI/ML powered device.
7. The type of ground truth used
The ground truth is established by objective technical standards and regulatory requirements:
- ASTM D3578-01aE2 Standard: This is a widely recognized standard specification for rubber examination gloves. It defines the acceptable ranges for physical properties like dimensions, tensile strength, elongation, and watertightness.
- FDA Water Leak Test: A specific FDA requirement for glove watertightness.
- FDA Minimum Powder Residual Content: A specific FDA requirement regarding the amount of powder on the gloves.
- Biocompatibility Tests: Standardized tests (Primary Dermal Irritation Test and Guinea Pig Sensitization (Buehler) test) to assess the biological response to the glove material.
8. The sample size for the training set
N/A. This is a manufactured product, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
N/A. This is a manufactured product, not an AI/ML model that requires a training set or its associated ground truth establishment.
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.